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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLEAD CAP ACCESSORY KIT
Generic Nameimplantable cardioverter defibrillator (icd) lead
ApplicantGUIDANT CORP.
PMA NumberP940008
Supplement NumberS015
Date Received06/26/2000
Decision Date10/05/2000
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the lead caps for use with all guidant compatible leads including the reliance(tm) and reliance s(tm) leads.
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